The following data is part of a premarket notification filed by Bio-rad with the FDA for Mrsaselect - Extended Incubation.
Device ID | K081212 |
510k Number | K081212 |
Device Name: | MRSASELECT - EXTENDED INCUBATION |
Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
Applicant | BIO-RAD 163 CABOT ST. Beverly, MA 01915 |
Contact | Fran White |
Correspondent | Fran White BIO-RAD 163 CABOT ST. Beverly, MA 01915 |
Product Code | JSO |
CFR Regulation Number | 866.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-29 |
Decision Date | 2008-06-13 |
Summary: | summary |